RADIAL 2 Heart Transplant Study: Left vs. Right Radial Approach Randomized Comparison for Routine Catheterization of Heart Transplant Patients

Orthotopic heart transplantation is a well established therapeutic measure for end stage heart failure, leading to significant improvements in survival and quality of life. Allograft vascular disease remains the most frequent cause of morbidity and mortality after orthotopic heart transplantation, with angiographic evidence of allograft vascular disease around 50% of patients at 5- to 15-year follow-up. In the routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac catheterization for early detection of allograft vascular disease.

The coronary angiography of these patients is characterized for several technical difficulties, generally related to the presence of the aortotomy with anomalous implantation of the coronary ostia and to the orthotopic position of the allograft. For these reasons, trans femoral approach is usually preferred. In the last two decades, trans radial approach for coronary angiography emerged to be effective, safe and able to improve patient comfort. However, there is no universal consensus about the optimal choice of radial access from either the left or the right artery. Currently, this choice is largely dependent on the operator's preference. The trans-right-radial approach is generally preferred in routine clinical practice mainly due to its easier catheter manipulation for the operators from patient's right side, and the current design of radial compression devices for the right wrist in medical market. As such, a major barrier to prevent the wide adoption of the left radial access lies in some difficulty to reach the left wrist leaning over the patient, particularly for shorter operators or in obese patients. However, a great deal of attention has been recently directed toward the trans-left-radial access, as it has an important anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the left coronary ostium, which could also reduce the risk of cerebrovascular complications.

In this context, a recent metanalysis demonstrated that trans left radial access is preferable to trans-right-radial approach in terms of fluoroscopy time and contrast use for the diagnostic or interventional coronary procedures. Moreover, as expected, there was an indication of lowered failure rate of radial access from the left than the right. No data are available about the performance of trans left radial access or trans right radial approach in coronary angiography of orthotopic heart transplantation patients. However, in this particular setting of patients, the trans-left-radial access might reduce the technical difficulties related to the anatomical variations.

In this single-centre, prospective, randomized study, we sought to compare trans right radial approach versus trans-left-radial access in terms of amount of contrast medium, radiation exposure, number of catheters used, cross-over to the other access site rate and local and systemic complications in orthotopic heart transplantation patients.

Study objectives